Global Health Challenges Spur Vaccine Development

It's flu season again, which always focuses public attention on the reliability and availability of the nation's vaccine supply. The Centers for Disease Control and Prevention (CDC) expect to have more vaccine available this season—166 million dosages versus 157 million in the 2010–2011 season—and have launched a major campaign to vaccinate more healthcare workers and pregnant women. Last year, about 42% of Americans were immunized, more than usual, but still far below the 80% goal set by the federal government. While the vaccine community won plaudits for responding quickly to the 2009–2010 influenza pandemic, the World Health Organization (WHO) came under fire for slow distribution of vaccines in poor countries, as well as charges that it hyped the danger of the epidemic to boost drug company sales. A blue-ribbon panel rejected those charges, but the debate reveals the highly-charged political environment surrounding immunization programs.

Vaccines have even made it into the Republican presidential race. Texas Governor Rick Perry publicly disavowed his earlier backing of the human papillomavirus (HPV) vaccine for all young girls. Perry signed an executive order in 2007 mandating that all sixth-grade girls in Texas receive Merck's Gardasil vaccine to prevent cervical cancer. Now, candidate Perry says he made a mistake—an about-face that reflects concerns raised by social conservatives about vaccine mandates overall, and specifically about endorsing a preventive for a sexually-transmitted disease.

Other important developments this year brought good news to vaccine producers and advocates. The US Supreme Court ruled in February that manufacturers cannot be sued in state courts for injuries allegedly caused by their products. The case, Bruesewitz v. Wyeth (Feb. 22, 2011), should discourage plaintiffs from trying to circumvent the protections created by the 1986 National Childhood Vaccine Injury Act, which provides compensation from the industry-funded Vaccine Injury Compensation Program (VCIP) to patients claiming injury from vaccines. This federal pre-emption of state-based injury suits is crucial for protecting manufacturers from costly tort litigation that would drive them from the vaccine business.

The high court's decision came on the heels of reports fully discrediting earlier studies linking vaccines and autism, a claim that has plagued vaccine makers for years. The British Medical Journal published a series of articles by journalist Brian Deer documenting that data published in a 1998 paper by British physician Andrew Wakefield and colleagues was not just bad science, but deliberate fraud (1). The Lancet, which had published Wakefield's original paper, retracted it in 2010, but too late to repair the extensive damage to public health from antivaccine forces, which has fostered a re-emergence of measles in the United Kingdom and in parts of the United States (2, 3).

Perennial concerns about vaccine safety prompted an in-depth analysis by the Institute of Medicine (IOM), which documents in great detail that vaccines cause few adverse effects and have no links to serious health conditions. The expert committee's August 2011 report on "Adverse Effects of Vaccines" finds little scientific evidence that of health problems caused by eight widely used vaccines, and further discredits links between the measles-mumps-rubella (MMR) vaccine and autism (4). The report confirms the huge health benefits of vaccines and should encourage more parents to vaccinate their children; it also will help the US Department of Health and Human Services (HHS) decide vaccine compensation cases under the VCIP program.